Ipilimumab and Nivolumab in Leptomeningeal Metastases (NCT02939300) | Clinical Trial Compass
CompletedPhase 2
Ipilimumab and Nivolumab in Leptomeningeal Metastases
United States18 participantsStarted 2018-02-15
Plain-language summary
This research study is studying a combination of two drugs as a possible treatment for Leptomeningeal Metastases.
The names of the study interventions involved in this study are:
* Ipilimumab
* Nivolumab
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically or cytologically confirmed disease from any solid tumor
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
* Life expectancy of greater than 3 weeks
* Participants must have normal organ and marrow function as defined below, all screening labs should be performed within 10 days of treatment initiation.
Adequate Organ Function Laboratory Values:
Unit key: mcL = microliter, ULN = upper limit normal
* Hematological
* Absolute neutrophil count (ANC) ≥1500 /mcL
* Platelets ≥100,000 / mcL
* Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or Erythropoietin (EPO) dependency (within 7 days of assessment)
* Renal
* Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
* Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
* Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
* Hepatic
* Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 ULN OR ≤ 5 X ULN for subjects with liver metastases
* Albumin ≥ 2.5 mg/dL
* Coagulation
* International Normalized Ratio (INR) or Prothrombi…